Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

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Stemgenex motion to dismiss aims to rebut stem cell suit claims

motion-to-dismiss-stemgenexSan Diego-based stem cell business Stemgenex is the subject of a suit over allegations about stem cell treatments. The company has now filed a motion to dismiss the case.

To me as a non-attorney, the Stemgenex motion to dismiss seems to emphasize overall vagueness of the plaintiff’s case and argues in part that there is insufficient detailed support of each claim.

From my reading of the plaintiff’s suit document, the case seems focused on alleged issues with Internet marketing claims and it provides details mainly on that level. Are all nine claims related to that? I’m not sure.

The motion to dismiss also asserts that there is a lack of detail on the specific alleged roles of each defendant as pertains to the nine claims. I’m more accustomed to reading, writing, and critiquing scientific materials (e.g. papers and grants), so court documents seem somewhat foreign to me and I don’t know what the expectations are for claims. I do feel like there are some lacunae in terms of specific details of the nine claims in the case, but is that par for the course at this stage?

Stay tuned as we all learn more about this situation and hopefully one or more experts in legal matters will weigh in on it.

South Africa grapples with “illegal” stem cell experiment scandal

dr-wian-standerSouth Africa is facing a stem cell scandal related to what a health policy news outlet called Spotlight there characterizes as illegal experiments by ReGenesis Biotechnologies, the company at the heart of the controversy. It had a contract with a governmental health provider agency, now apparently suspended.

The report begins this way: “The Medicines Control Council (MCC) this week suspended what appears to be unlawful stem cell experimentation at Pelonomi, a state hospital in Bloemfontein.”

However, there does not appear to be concrete data supporting safety and efficacy of the “treatments” in question. There were additional concerns over informed consent:

“MCC Chairperson Professor Helen Rees confirmed to Spotlight that inspectors had been to the Pelonomi site last Friday and again on Monday.

“Our concern was that the service level agreement made reference to medicines, injections and therapeutic research,” said Rees.

She said the informed consent documents referred to the patients giving permission for stem cell therapy, permission for stem cells to be removed, concentrated and re-injected and for their stem cells to be given to another person.”

The leader of the company was reported as Dr. Wian Stander.

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LA Times Shines Some Light on Stem Cell Clinics including StemGenex

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example.StemGenex

He started off with a description of the kind of hopeful feeling that many patients experience upon visiting stem cell clinic websites:

“Visitors to the website of StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand.”

However, there is little published data to support the expectation that one’s prayers might be answered at U.S. stem cell clinics today. I talked with Hiltzik about the state of the American stem cell clinic arena and my concerns as he was researching his piece. The marketing of stem cells is too aspirational in my view and patients are sold medical interventions in many cases that may not work and have potential risks. Hiltzik writes (emphasis mine):

“StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”

Keep in mind that we are talking about hundreds of clinics in the U.S. injecting living stem cells into patients’ bloodstreams or into specific tissues and most clinics out there do not have FDA approval to do this so anecdotes are not a strong foundation for this kind of practice in my opinion.

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New paper shows huge American stem cell clinic industry: 570 locations

My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses.

These numbers are way beyond the predictions of most researchers and policy makers for stem cell clinics in the U.S., and point to a burgeoning, huge industry from coast to coast (see map below of clinic locations that we found in our research that is Figure 1 of the paper).

Figure 1 Turner Knoepfler Stem Cell Clinics

We focused on those businesses that as best as we could determine do not have FDA approval for marketing stem cell treatments. This means that even if relatively few patients are seen at each of the 570 locations, tens of thousands of Americans each year may be getting stem cell offerings that do not have formal FDA approval.

The businesses in general market fat, bone marrow, and amniotic-related stem cells for a surprisingly wide range of conditions too, pretty much from head to toe and A to Z in a medical dictionary of conditions. It’s not clear scientifically if there are data to concretely support the use of these types of stem cells for such a wide spectrum of conditions.

Our goal was to document this direct-to-consumer marketed industry as fully as possible even as we excluded those businesses that had INDs or operated outside the U.S. A challenge in that regard is that the FDA keeps information about INDs private.

Importantly on the other hand some businesses while having no formal FDA approval may still be compliant because they fall within specific categories of usage. For instance, in some cases with a subset of these clinics such as those that use largely unmodified bone marrow cells for autologous use in homologous orthopedic conditions, no FDA “drug” approval is likely needed.

However, in many other kinds of treatment scenarios that we documented there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

Still, I do not condone the use of words like “non-compliant” or “shady” to describe all at once this entire clinic marketplace or to characterize the full list of businesses in our database because of a number of reasons including the issue mentioned above with bone marrow being used in a homologous way in some cases as well as the overall complexity of this arena and the lack of clarity from the FDA.

I’ll have more to say about the paper, but I hope you find it a valuable resource.